The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified August 2010 by State University of New York - Upstate Medical University. Recruitment status was: Not yet recruiting

Sponsor:

State University of New York - Upstate Medical University

ClinicalTrials.gov Identifier:

NCT00759733

First Posted: September 25, 2008

Last Update Posted: August 5, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Maternal cardiac disease complicates approximately 2 percent of pregnancies and is the leading cause of non-obstetrical maternal death. Evaluating cardiac function and dysfunction is a complex process requiring skilled clinicians and technology such as ECG, long-term monitoring, and echocardiography. A fast, easily obtained blood test for B-type natriuretic peptide (BNP) has been developed that can give evidence for heart muscle stretch and dysfunction among adults with suspected congestive heart failure. Preliminary experience indicates that ventricular dysfunction among OB patients with a history of heart disease can be detected with this serum assay. A prospective cohort design consisting of two groups of pregnant patients; one with a history of cardiac disease and one without, will be followed over the course of the pregnancies and cardiac function will be measured using echocardiography and serum BNP. It is hoped that the blood test for BNP will be a reliable way to help evaluate OB patients with suspected abnormal heart function.

Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:

Assess cardiac function on echocardiography and with serum B-type natriuretic peptide for women with a history of cardiac disease and for a control group with no history of heart disease over the course of pregnancy and compare the groups [ Time Frame: first, second, third trimesters of a 40-week pregnancy ]

Secondary Outcome Measures:

Assess for the presence of cardiac dysfunction in the course of a 40-week pregnancy [ Time Frame: first, second, third trimesters of pregnancy ]

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Ages Eligible for Study:

18 Years to 50 Years (Adult)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Sampling Method:

Non-Probability Sample

Study Population

pregnant women at least 18 years of age with a history of cardiac disease for the study group and a second group of pregnant women at least 18 years of age with no history of heart disease as controls